PHUSE India Single Day Event Success and How we Support Pharmacovigilance this Medication Safety Week

#MedSafetyWeek highlights the importance of medicines in improving health and the need for sufficient safety testing. Navitas Life Sciences is a global Clinical Research Organization focused on supporting clinical trial needs of small, medium and large life sciences companies. We deliver platform-driven end-to-end clinical trials right from clinical trials operations, medical services, regulatory, pharmacovigilance and clinical data services.

PHUSE India Single Day Event

PHUSE is a Global Healthcare Data Science Community where ideas, tools, and standards around data, statistical, and reporting technologies are shared. Shrishaila Patil, Senior Vice President, Navitas Data Sciences, has been nominated as PHUSE India's Single Day Event Lead. The PHUSE India Autumn Single Day Event, conducted on 17 September 2022, was Shrishaila Patil’s third event in his role as India SDE Lead for 2022.

We met with Shrishaila Patil to understand what made PHUSE India Autumn Single Day Event a success.

Describe your professional journey

I have a master’s degree in Biotechnology from Bangalore University and approximately 18 years of experience in Drug Development. I am the Senior Vice President at Navitas Data Sciences, heading the Statistical Programming department, India.

I am a "CDISC Volunteer" & "PHUSE India Events Officer." I have supported the "R Package Validation Framework" and "Open-Source Technologies for Regulatory Submissions" projects in the PHUSE working group "Data Visualization and Open-Source Technology in Clinical Research (DVOST)."

I have authored a book titled, "FDA Clinical Outcome Assessments and CDISC QRS supplements," under the "Clinical disciplines" category with the LAMBERT Academic Publishing Group.

Shrishaila Patil

Senior Vice President,

Navitas Data Sciences

Tell us more about the PHUSE India Autumn Single Day Event?

PHUSE India Autumn Single Day Event (SDE) was scheduled on 17 Sep 2022 (Saturday). After 2019 (Oct2019 PHUSE India SDE), this was the first physical Single day event planned in India. The registration for the event was free & open to all.

This was a hybrid event and was held at the GSK Office, Bangalore. Participants had the option to either attend it physically or virtually.

The theme of discussion was “Data Analysis and Reporting of New Age Clinical Trials (Automation in Clinical Programming, Standards, Latest Protocol Designs, RWD, RWE, etc.)”. We had interesting presentations on topics like “Innovation & Patient centricity”, “Master Protocols”, “RWD & RWE”, “Cloud based analytics solutions”, “Automation” and “Developing datasets for Synthetic Control arms” etc.

You can access the recorded event using the link provided below: https://gateway.on24.com/wcc/eh/2309258/category/98907/single-day-events-2022

What was the response for the event?

We had a great response and over 500 people registered for the PHUSE Autumn Single day event. There was a lot of positive feedback from the participants and industry peers.

The event was very successfully conducted Physically at GSK facility with great support from their Leadership, IT & Facilities teams.

We were also able to seamlessly manage online participants using digital tools and we received outstanding support from Chairs, Speakers, Panel members & Volunteers.

What were the key topics discussed?

There were multiple topics discussed, like

• Innovation and Patient Centri
• Master Protocols – An Introduction
• Utilise Real-world Evidence (RWE) to Coverage Decisions in 10 Different Evidence Types
• Advanced Cloud-based Analytical Solution – Microsoft Azure Data Analytics
• Usage of eCOA in Clinical Trials
• Automating SDTM Specification Creation
• Challenges in Developing Datasets for Synthetic Control Arms
• Automation by Macros in SAS Programming

What was the feedback from participants?

As per feedback survey, overall most participants rated the event as Excellent & they appreciated the Quality of Presentations, as well as the way the event was conducted. They highly recommend PHUSE SDE attendance to their colleagues. Many of them want to be PHUSE volunteers & present in upcoming events.

Participants were asked What they liked most about the event. We received multiple responses, including the following responses for what they liked

• Networking
• Presentations
• Good Range of Topics
• Insightful Panel Discussion

Navitas Data Sciences- Statistical Programming Functional Service Provider

Navitas Data Sciences (a part of Navitas Life Sciences) builds bespoke teams of highly skilled Statistical Programmers (both US-based and Global Programmers), Biostatisticians, and Data Managers. The experience level of our professional resources, coupled with our vast experience in managing studies of different sizes and phases, provides for an advanced, efficient, and smart work model for our sponsorsto take their drugs to the market faster.

How we support Pharmacovigilance

Navitas Life Sciences has been at the forefront of new developments in Pharmacovigilance for more than 30 years. Our Consulting Team has defined and implemented PV processes, governance practices and even organizations in more than 300 Life Sciences companies.

Many of the top 100 biopharma companies are members of pvnet or pvconnect, our Safety Networks. They benefit from round-the-year insights on operational performance, compliance and the latest trends highlighted during our forums, and frequent interactions with our experts. This wealth of experience and PV knowledge combined with our Technology capabilities is utilized across all our PV services and solutions.

To find out more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.